BEUDAMED
    FDA Recall Terminated

    FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139

    Recall: Z-2262-2015 · Initiated June 24, 2015

    Recall

    Recall Number
    Z-2262-2015
    Event Number
    71663
    FEI Number
    1000116912
    Product Code
    HWT
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 24, 2015
    Posted
    July 27, 2015
    Terminated
    June 24, 2016
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    Description

    FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139

    Reason

    The markings on the distal face of the instruments are mis-oriented by 180. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrument in the A/P direction is critical to making proper anterior, posterior, and chamfer cuts to fit the femoral implant.

    Action

    DJO Surgical sent an " Urgent Field Safety Notice" dated June 30, 2015, to the affected customer. The recalling firm requested the customer return the affected product for a replacement. For further questions, please call (512) 834-6302.

    Distribution

    US Distribution to TX and GA.

    Quantity

    10 units